K244060
- 510(k) number
- K244060
- Device name
- eCO2 3D
- Applicant
- Lutronic Corporation KR
- Product code
- ONG — Powered Laser Surgical Instrument With MicrobeamFrac
- Decision date
- 2025-07-31
- Date received
- 2024-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K244060.pdf
Official FDA record: K244060
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.